Neoantigen vaccines for treating esophageal cancer
Official title: Neoantigen Vaccines in Combination with Immune Checkpoint Inhibitors for Maintenance Therapy Following Definitive Treatment of Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: an Open-Label, Randomized, Phase II Study
Run by Sichuan University · NCT06675201 · Data updated 2026-11-12
This study is testing a new vaccine for people with advanced esophageal cancer to see if it can help them live longer and feel better after their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 165 (estimated) |
| Sponsor | Sichuan University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Chengdu, Please Select) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | November 5, 2024 |
| Trial ID | NCT06675201 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with locally advanced unresectable ESCC who have undergone radical treatment and can provide fresh tumor tissue samples.
✕Probably not a fit
Patients with a history of gastrointestinal complications or those with poor nutritional status may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of a neoantigen-loaded dendritic cell vaccine as a consolidation therapy for patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC) following radical chemoradiotherapy. The study aims to determine if combining this vaccine with immune checkpoint inhibitors can improve overall survival and quality of life. Participants will undergo diagnostic endoscopy and provide fresh tumor tissue samples for neoantigen identification. The trial will assess various endpoints, including overall survival rates, progression-free survival, and quality of life metrics.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced esophageal cancer.
How similar studies have gone: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: A. Age 18-80 years B. Locally advanced unresectable ESCC patients after radical treatment (radical chemoradiotherapy or chemoradiation); including: * Cervical esophageal segment, T4, supraclavicular lymph node metastasis, or inability/refusal to undergo surgery due to personal reasons (refer to hospital below); ② Failure of neoadjuvant or conversion therapy; ③ Postoperative local recurrence, unresectable (target lesion present). C. No evidence of tumor recurrence or metastasis 2-3 weeks after radical treatment D. Ability to provide fresh tumor tissue samples (baseline) E. Normal major organ function F. Performance status (PS) score ≤ 1 G. Patients of childbearing potential must use contraception H. Voluntary participation with signed informed consent Exclusion Criteria: A. History of fistula caused by primary tumor invasion B. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation C. Poor nutritional status D. Immune-related adverse events during prior radical treatment, such as Grade ≥3 pneumonitis, myocarditis, etc. E. Signs and symptoms of interstitial diseases F. Presence of any severe and/or uncontrolled medical conditions G. Presence of concurrent malignancies H. Presence of other autoimmune diseases, or prolonged use of immunosuppressants or steroids I. Difficulty in patient communication or inability to comply with long-term follow-up J. Other conditions deemed unsuitable by the investigator
Where it's running
-
West China Hospital of Sichuan University
Chengdu, Please Select, China Recruiting
Study contacts
- Principal investigator: zhenyu ding, MD — West China Hospital of Sichuan University, ChengDu, China
- Study coordinator: zhenyu ding, MD
- Email: dingzhenyu@scu.edu.cn
- Phone: +86 028-854-22562
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CR-002 study in adults with advanced solid tumors
This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors
-
Neoadjuvant CTLA-4 and PD-1 blockade with chemoradiotherapy for locally advanced ESCC
This trial tests whether giving two immune checkpoint inhibitors before surgery, together with chemoradiotherapy, helps patients with resectable locally advanced esophageal squamous cell carcinoma.
-
PD-1 inhibitors with local therapy at different timings in oligometastatic ESCC
This study tests whether giving local radiotherapy at different times around PD-1 inhibitor therapy helps people with oligometastatic esophageal squamous cell carcinoma.
-
Adebrelimab plus chemotherapy before surgery for borderline-resectable esophageal squamous cell carcinoma
This trial tests whether adding adebrelimab to chemotherapy given before surgery can shrink borderline-resectable ESCC enough to allow curative tumor removal.
-
Adebrelimab with neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma
This study tests whether giving adebrelimab with paclitaxel, carboplatin, and short-course radiotherapy before surgery helps ESCC patients.
-
Starting chemo plus PD-1 immunotherapy before radiation versus giving chemo during radiation for unresectable locally advanced esophageal squamous cell carcinoma
This trial sees if giving three cycles of chemotherapy with a PD-1 immunotherapy before radiation, followed by maintenance immunotherapy, works better than giving chemotherapy at the same time as radiation followed by the same maintenance for people with unresectable locally advanced esophageal squamous cell carcinoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.